Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1174-1290 | Registry Identifier | WHO | |
| JapicCTI-153019 | Registry Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.
This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg-derived TIV.
The drug being tested in this study is called TAK-850. TAK-850 was tested in healthy volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared to an egg-derived influenza vaccine.
The study enrolled 400 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-850 | Experimental | A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm. |
|
| Influenza HA Vaccine | Active Comparator | A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-850 | Biological | TAK-850 subcutaneous injection |
| |
| Influenza HA vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10. | Baseline and Day 22 |
| Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference. | Days 1 and 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference. | Days 1 and 22 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
Not provided
Healthy Volunteers were enrolled equally in 1 of 2 groups, TAK-850 subcutaneous (SC) or Influenza hemagglutinin (HA) vaccine SC.
Participants took part in the study at 1 investigative site in Japan from 24 September 2015 to 18 November 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TAK-850 | A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm. |
| FG001 | Influenza HA Vaccine | A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized Set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TAK-850 | A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm. |
| BG001 | Influenza HA Vaccine | A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10. | Full Analysis Set (FAS) included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Day 22 |
|
22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-850 | A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
Influenza HA vaccine subcutaneous injection |
|
| Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline. | Baseline and Day 22 |
| Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. | Baseline and Day 22 |
| GMT of SRH Antibody Titer (Egg-Derived Antigen) | GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | Days 1 and 22 |
| Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | Days 1 and 22 |
| Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. | Baseline and Day 22 |
| Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of <10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. | Baseline and Day 22 |
| GMT of HI Antibody Titer (Vero-Derived Antigen) | GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | Days 1 and 22 |
| Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | Days 1 and 22 |
| Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. | Baseline and Day 22 |
| Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. | Baseline and Day 22 |
| GMT of SRH Antibody Titer (Vero-Derived Antigen) | GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | Days 1 and 22 |
| Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | Days 1 and 22 |
| Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. | Baseline and Day 22 |
| Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting. | 22 Days |
| Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | 22 days |
| Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs. | 22 Days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Influenza Infection within 1 Year | Number | participants |
|
| Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived)-A/H1N1 Strain | HI Antibody Titer data is only available for N=199, 200 respectively. | Number | participants |
|
| HI Antibody Titer (Egg-derived)-A/H3N2 Strain | HI Antibody Titer data is only available for N=199, 200 respectively. | Number | participants |
|
| HI Antibody Titer (Egg-derived)-B Strain | HI Antibody Titer data is only available for N=199, 200 respectively. | Number | participants |
|
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
| OG001 | Influenza HA Vaccine | A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. |
|
|
|
| Primary | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 1 and 22 |
|
|
|
|
| Secondary | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1 and 22 |
|
|
|
| Secondary | Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Baseline and Day 22 |
|
|
|
| Secondary | Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Day 22 |
|
|
|
|
| Secondary | GMT of SRH Antibody Titer (Egg-Derived Antigen) | GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Geometric Mean | 95% Confidence Interval | mm^2 | Days 1 and 22 |
|
|
|
|
| Secondary | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1 and 22 |
|
|
|
| Secondary | Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Baseline and Day 22 |
|
|
|
| Secondary | Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of <10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Day 22 |
|
|
|
|
| Secondary | GMT of HI Antibody Titer (Vero-Derived Antigen) | GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 1 and 22 |
|
|
|
|
| Secondary | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1 and 22 |
|
|
|
| Secondary | Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. | FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Baseline and Day 22 |
|
|
|
| Secondary | Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Day 22 |
|
|
|
|
| Secondary | GMT of SRH Antibody Titer (Vero-Derived Antigen) | GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 1 and 22 |
|
|
|
|
| Secondary | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1 and 22 |
|
|
|
| Secondary | Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. | FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Baseline and Day 22 |
|
|
|
| Secondary | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting. | Safety Analysis Set included all participants who received vaccination with study vaccine. | Posted | Number | percentage of participants | 22 Days |
|
|
|
| Secondary | Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Analysis Set included all participants who received vaccination with study vaccine. | Posted | Number | percentage of participants | 22 days |
|
|
|
| Secondary | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs. | Safety Analysis Set included all participants who received vaccination with study vaccine. | Posted | Number | percentage of participants | 22 Days |
|
|
|
| 0 |
| 200 |
| 117 |
| 200 |
| EG001 | Influenza HA Vaccine | A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. | 0 | 200 | 122 | 200 |
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| A/H3N2 Strain-Day 1 |
|
| A/H3N2 Strain-Day 22 |
|
| B Strain-Day 1 |
|
| B Strain-Day 22 |
|
The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22. |
| Ratio of GMTs |
| 0.76 |
| 2-Sided |
| 95 |
| 0.5544 |
| 1.0500 |
TAK-850/Influenza HA Vaccine |
| Yes |
| Non-Inferiority or Equivalence |
Non inferiority margin is set to 0.5. |
| The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22. | Ratio of GMTs | 1.06 | 2-Sided | 95 | 0.8134 | 1.3931 | TAK-850/Influenza HA Vaccine | Yes | Non-Inferiority or Equivalence | Non inferiority margin is set to 0.5. |
| A/H3N2 Strain-Day 1 |
|
| A/H3N2 Strain-Day 22 |
|
| B Strain-Day 1 |
|
| B Strain-Day 22 |
|
| B Strain |
|
| B Strain |
|
The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.
| Rate difference |
| -8.8 |
| 2-Sided |
| 95 |
| -18.282 |
| 0.901 |
| Yes |
| Non-Inferiority or Equivalence |
Non inferiority margin is set to -20%. |
| The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22. | Rate difference | -2.3 | 2-Sided | 95 | -11.461 | 6.835 | Yes | Non-Inferiority or Equivalence | Non inferiority margin is set to -20%. |
| A/H3N2 Strain-Day 1 |
|
| A/H3N2 Strain-Day 22 |
|
| B Strain-Day 1 |
|
| B Strain-Day 22 |
|
The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22. |
| Ratio of GMTs |
| 0.90 |
| 2-Sided |
| 95 |
| 0.7862 |
| 1.0241 |
TAK-850/Influenza HA Vaccine |
| Yes |
| Non-Inferiority or Equivalence |
Non inferiority margin is set to 0.5. |
| The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22. | Ratio of GMTs | 0.98 | 2-Sided | 95 | 0.9273 | 1.0364 | TAK-850/Influenza HA Vaccine | Yes | Non-Inferiority or Equivalence | Non inferiority margin is set to 0.5. |
| A/H3N2 Strain-Day 1 |
|
| A/H3N2 Strain-Day 22 |
|
| B Strain-Day 1 |
|
| B Strain-Day 22 |
|
| B Strain |
|
| B Strain |
|
The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.
| Rate difference |
| -1.9 |
| 2-Sided |
| 95 |
| -10.614 |
| 6.928 |
| Yes |
| Non-Inferiority or Equivalence |
Non inferiority margin is set to -20%. |
| The analysis is difference of seroconversion rate between treatment groups for B-Strain. | Rate difference | -2.4 | 2-Sided | 95 | -10.346 | 5.579 | Yes | Non-Inferiority or Equivalence | Non inferiority margin is set to -20%. |
| A/H3N2 Strain-Day 1 |
|
| A/H3N2 Strain-Day 22 |
|
| B Strain-Day 1 |
|
| B Strain-Day 22 |
|
The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22. |
| Ratio of GMTs |
| 1.07 |
| 2-Sided |
| 95 |
| 0.7806 |
| 1.4564 |
TAK-850/Influenza HA Vaccine |
| Yes |
| Non-Inferiority or Equivalence |
Non inferiority margin is set to 0.5. |
| The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22. | Ratio of GMTs | 1.07 | 2-Sided | 95 | 0.8166 | 1.3934 | TAK-850/Influenza HA Vaccine | Yes | Non-Inferiority or Equivalence | Non inferiority margin is set to 0.5. |
| A/H3N2 Strain-Day 1 |
|
| A/H3N2 Strain-Day 22 |
|
| B Strain-Day 1 |
|
| B Strain-Day22 |
|
| B Strain |
|
| B Strain |
|
The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22. |
| Rate difference |
| -0.8 |
| 2-Sided |
| 95 |
| -10.369 |
| 8.803 |
TAK-850 - Influenza HA Vaccine |
| Yes |
| Non-Inferiority or Equivalence |
Non inferiority margin is set to -20%. |
| The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22. | Rate difference | 3.2 | 2-Sided | 95 | -6.406 | 12.757 | TAK-850 - Influenza HA Vaccine | Yes | Non-Inferiority or Equivalence | Non inferiority margin is set to -20%. |
| A/H3N2 Strain-Day 1 |
|
| A/H3N2 Strain-Day 22 |
|
| B Strain-Day 1 |
|
| B Strain-Day 22 |
|
The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22. |
| Ratio of GMTs |
| 0.98 |
| 2-Sided |
| 95 |
| 0.8686 |
| 1.0969 |
TAK-850/Influenza HA Vaccine |
| Yes |
| Non-Inferiority or Equivalence |
Non inferiority margin is set to 0.5. |
| The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22. | Ratio of GMTs | 1.05 | 2-Sided | 95 | 0.9622 | 1.1427 | TAK-850/Influenza HA Vaccine | Yes | Non-Inferiority or Equivalence | Non inferiority margin is set to 0.5. |
| A/H3N2 Strain-Day 1 |
|
| A/H3N2 Strain-Day 22 |
|
| B Strain-Day 1 |
|
| B Strain-Day 22 |
|
| B Strain |
|
| Injection site swelling |
|
| Injection site induration |
|
| Injection site ecchymosis |
|
| Pyrexia |
|
| Malaise |
|
| Chills |
|
| Fatigue |
|
| Headache |
|
| Sweaty |
|
| Myalgia |
|
| Arthralgia |
|
| Nausea |
|
| Vomiting |
|
| Blood bilirubin increased |
|
| Liver function test abnormal |
|
| White blood cell count increased |
|
| Alanine aminotransferase increased |
|
| Blood glucose increased |
|